Glaxo Gets Positive EMEA Opinion on Its Cancer Drug Tykerb

The world’s second-biggest drugmaker, GlaxoSmithKline PLC said Friday that the European Medicines Agency (EMEA) has given a favorable vote on the company’s breast cancer drug Tyverb and received a conditional marketing approval.

The drug, also known as lapatinib, is a small molecule, which combined with capecitabine, is recommended for patients who have advanced breast cancer or breast cancer that has spread to other parts of the body, especially brain.

Lapatinib is the first oral drug that works by entering the cancer cell to inhibit both ErbB1 and ErbB2, the two receptor proteins that are responsible for tumor growth.

The ruling was received as good news for thousands of women in Europe diagnosed each year with aggressive breast cancer, said Martine Piccart, professor of oncology at the Universite Libre de Bruxelles.

"Lapatinib represents an important new treatment option for a group of patients in real need of alternative therapies, and I look forward to the day that I can prescribe lapatinib," she said, according to the Houston Chronicle.

The news is a boost for Glaxo, which is aiming to increase its position in the fast-growing cancer market. The conditional approval – if endorsed by the European commission within a couple of months, as expected – means the drug can sold immediately but that additional clinical data are still required.

The medicine is already on sale in the United States, but with a slightly modified name, Tykerb. In a brain cancer trial, Tykerb, used with Roche Holding AG’s drug Xeloda, shrank the size of tumors by at least 20 percent in 18 of 47 women participating at the trial. Moreover, 10 of those 18 patients had brain tumors reduced to half the original size, the researchers at the college’s Breast Care Cancer said in a December 14 telephone interview.

“This is the first small proof we're going in the right direction. In the future, we may figure out ways to block the stem cells and eradicate breast cancer,” Jenny Chang, the lead researcher and medical director at the college’s BCC said.

Administered as a pill, Tykerb seems to be more convenient than Roche and Genentech Inc’s Blockbuster Herceptin, which works in similar way but must be injected.

The finding is significant because about one third of women with advanced breast cancer who carry the HER-2 gene develop tumors in the central nervous system, including the brain. Chemotherapy, radiation or surgery numbers among the current treatment for tumors that spread to the brain.